Thalomid May Cause Serious Side Effects. Thalomid (thalidomide) capsules are used to treat multiple myeloma, which is a cancer of the plasma cells; these are a type of white blood cell that helps the immune system protect the body against germs and other harmful substances. But while Thalomid is supposed to treat cancer, it can actually cause secondary cancers in some patients, according to Canadian health regulators. Thalomid is manufactured by Celgene Inc.

On April 8, 2013, Celgene Inc. joined with overseas regulators the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency (MHRA) to issue a communication about the risks of thalomide in the European Union, where the drug is licensed for use in combination with melphalan and prednisone as a first-line treatment for patients with untreated multiple myeloma who are 65 or older, or are ineligible for high-dose chemotherapy.

The same risks issued in that communication where reiterated on May 16, 2013, when Health Canada, the country’s health regulatory agency, and Celgene Inc. issued another letter to doctors, pharmacists and other healthcare professionals to inform them about the potential of Thalomid to cause secondary cancers. According to the letter, taking Thalomid can lead to “secondary primary malignancies,” or secondary cancers, such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). These cancers were seen in patients who took Thalomid in combination with the drugs melphalan and prednisone. Health Canada told healthcare professionals that the risk of AML and MDS should be taken into account before considering the use of Thalomid with these other medications. This information was added to Thalomid’s safety information.

Acute myeloid leukemia is a cancer that affects the myeloid blood cells, leading to a rapid growth of abnormal white blood cells that disrupts normal blood cell production. AML, if not treated, is often fatal within weeks or months. Signs of AML, according to Mayo Clinic, include:

Fever

Bone pain

Lethargy and fatigue

Shortness of breath

Pale skin

Frequent infections

Easy bruising

Unusual bleeding, such as frequent nosebleeds and bleeding from the gums

Thalomid’s Other Risks Include Deadly Blood Clots

Additional cancers are not the only side effect associated with Thalomid. Just weeks before Health Canada issued its warning letter, the agency issued a safety warning stating that Thalomid may cause a risk of blood clots in the arteries, which are the body’s major blood vessels. These arterial blood clots are most likely to happen during the first five months of Thalomid usage. If such a clot were to enter the heart, symptoms would include:

Chest pain that spreads to the arms, neck, jaw, back or stomach

Nausea

Sweaty, out of breath

If the blood clot is carried into the brain, the patient may experience a stroke and suffer from difficulty with seeing or speaking.

Thalidomide became infamous in the 1960s, when it was realized that the drug could cause severe birth defects when taken by pregnant women. Even a single dose could harm the unborn by causing limb deformities or even death.

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